Kornimate/medical-research-clean huggingface dataset:
functional magnetic resonance imaging of n-acetylcysteine in cocaine dependence

Conditions: Cocaine Dependence

Summary: the objective of this research is to identify the functional neural mechanisms (as assessed using fmri) of short-term n-acetylcysteine (nac) administration among methadone-maintained individuals with cocaine dependence.

the objective of this research is to identify the functional neural mechanisms (as assessed using fmri) of short-term n-acetylcysteine (nac) administration among methadone-maintained individuals with cocaine dependence. specifically, this application proposes to conduct a randomized, double-blind, placebo-controlled, cross-over pilot study to examine the effects of 7-day nac administration (2400mg/day) on the neural networks engaged during response inhibition (go/no-go task) and affective (emotion-regulation task) processes among cocaine-dependent, methadone-maintained individuals (n=40; 20 per treatment-order condition).

Eligibility criteria:
inclusion criteria: 1. enrollment in the apt methadone program and maintained on a stable dose of methadone for ≥ 2 weeks 2. males or females, aged 18-65 3. confirmed dsm-iv diagnosis of current cocaine use disorder as assessed at the screening assessment 4. for women of a child-bearing age, acceptable birth control method 5. ability to commit to 4 weeks of study participation plus 1-month follow-up 6. willingness to be randomized to nac or placebo 7. eligibility for mri scanning and willingness to participate in mri scanning. exclusion criteria: 1. do not meet dsm-iv criteria for cocaine-use disorder. 2. meet dsm-iv psychiatric classifications for lifetime schizophrenia or bipolar disorder, or exhibit significant current suicidal or homicidal plans and intent such that hospitalization is required. 3. meet dsm-iv criteria for current alcohol or other substance-use disorder dependence (with the exceptions of nicotine, cocaine and opioids). 4. have previously taken or currently take nac. 5. have asthma (due to possible complications with nac). 6. cannot commit to 4-weeks of study participation or are unwilling to accept randomization. 7. have any contraindications for mri scanning (e.g., pregnancy, color-blindness, claustrophobia, metal implants that could interfere with mri, any other contraindication to scanning). 8. have lab work (complete blood count, urinalysis, liver function tests, thyroid function tests) suggesting the presence of any abnormalities or have a significant or unstable medical illness. 9. are women who are pregnant or of a child-bearing age who do not agree to adequate contraception to prevent pregnancy during the study period. 10. are not fluent in english. 11. do not have at least a 6th grade reading level. 12. cannot provide written, informed consent.
clinical evaluation of the aptima® hpv 16 18/45 genotype assay on the panther® system

Conditions: Human Papillomavirus Infection

Summary: the objective of the clinical study is to evaluate the ahpv-gt assay using the panther system in cervical cancer screening. this objective will be accomplished in the asc-us study by evaluating the performance characteristics of the ahpv-gt assay using the panther system in a sample population of women with asc-us pap test results who were 21 years of age or older ("≥21 years of age") at the time of their pap visit. for the adjunct study, this objective will be accomplished by evaluating the ability of the ahpv-gt assay using the panther system to identify women at increased risk of cervical disease in a sample population of women with negative (nilm)cytology results who were ≥30 years of age at the time of their pap visit.


Eligibility criteria:
inclusion criteria: subjects who were previously enrolled into the prospective, multicenter us clinical study for the aptima hpv assay on the tigris system (protocol 2007hpvascus30) will be eligible for inclusion in the study of the ahpv-gt assay using the panther system described in this protocol. all evaluable asc-us study subjects ≥21 years of age will be eligible for inclusion. evaluable adjunct study subjects ≥30 years of age will be eligible if the following criteria are met: * the subject attended the colposcopy visit, or * the subject did not attend the colposcopy visit but the referral pap sample had a positive aptima hpv assay result in the aptima hpv assay tigris system study (protocol 2007hpvascus30) or in the aptima hpv assay panther system study (protocol ahpvps-us11-003). exclusion criteria: eligible subjects will be excluded if they do not have an evaluable sample. this may be due to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).

Keywords: cervix cancer hpv aptima
treatment of infected surgical wounds with negative pressure topical therapy and instillation (with or without antiseptic) versus no instillation

Conditions: Infected Surgical Wound

Summary: the objective of this study is to evaluate the effectiveness of ptni therapy versus ptn therapy without instillation in the treatment of infected surgical wounds. investigators mean to verify differences of effectiveness between the different types of instilled substances, normal saline versus amukine med 0.5%.


Eligibility criteria:
inclusion criteria: * patients with infected surgical wounds. * patient age greater than or equal to 18 years. * patients who have given informed consent to the enrollment in the trial and to the processing of personal data. exclusion criteria: * patients unable of consent. * patients affected by serious medical conditions that, according to the investigator's opinion, represent a contraindication to the study participation. * patients affected by wounds with exposition of blood vessels, sutures, organs or nerves and open wounds in mediastinum or abdomen. * patients with malignancy at the wound. * patients with untreated osteomyelitis. * patients with enteric and unexplored fistulas. * patients with necrotic tissue and eschar. * immunocompromised patients or in treatment with corticosteroids. * suspected or known allergic diathesis to the product of medication. * patients with coagulation disease.

Keywords: negative-pressure wound therapy topical negative pressure therapy sodium hypochlorite
study of xiap antisense for advanced cancers

Conditions: Advanced Cancer

Summary: this study is designed to find the maximum tolerated dose, safety and toxicity profile, and to identify any dose limiting toxicities of aeg35156 administered in 2-hour infusions to patients with advanced cancers.

this is a phase i study, single-arm, open-label, dose escalation study to establish the recommended dose and activity of aeg35156 administered as a 2-hour daily infusion over 3 days initially followed by weekly 2-hour intravenous infusions in patients with advanced cancers. subjects eligible for study entry must have proven advanced or metastatic cancer refactory to conventional treatment or for which no conventional therapy exists. the starting dose will be a fixed dose of 60 mg/day with escalation by steps of 50 to 100% in successive cohorts. approximately of 30 patients will be entered in the study to determine the maximum tolerated dose.

Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of advanced or metastatic cancer (including solid tumours and lymphoma) * refractory to conventional treatment, or for which no conventional therapy exists with life expectancy of at least 12 weeks * ecog performance status of 0 or 1 * hematological and biochemical indices as specified within one week prior to treatment exclusion criteria: * known bleeding diathesis or concurrent treatment with anticoagulants * primary brain tumours or brain metastases * radiotherapy (except palliative), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas and mitomycin-c) * all toxic manifestations of previous treatment must have resolved (excepting alopecia or certain grade 1 toxicities) * pregnant or lactating women * major thoracic and/or abdominal surgery in the preceding 4 weeks * high medical risks from non-malignant systemic disease including uncontrolled infection * hepatitis b, c or human immunodeficiency virus * allergic history to antisense agents

Keywords: cancer solid tumours refractory antisense oligonucleotide
psychological interventions in children after road traffic accidents or burns

Conditions: Acute Stress Disorder

Summary: within a randomized controlled design the effects of a brief early psychological intervention (child, parents) after road traffic accidents or burns shall be examined in a sample of 120 children and adolescents (aged 2 to 16 years). during the first seven days after the accident a screening for the risk of developing a posttraumatic stress disorder is conducted to divide the participants into a "high risk" and a "low risk" group. participants with a low risk are excluded from the intervention study but reassessed six months after their accident to validate the screening instrument. after a baseline assessment within 14 days after the accident participants of the high risk group are randomly assigned to an intervention group (n = 60) or a control group (n = 60). the latter receive standard medical care. children of the intervention group are provided with a brief age appropriate two-session intervention that includes a detailed reconstruction of the accident, psychoeducation and discussion of helpful coping strategies. both the control and the intervention group are reassessed by blind raters at 3 and 6 months after the accident. assessment of outcome includes measures of posttraumatic stress symptoms, depression, anxiety, behavior, and health-related quality of life.


Eligibility criteria:
inclusion criteria: * age 2-16 years * glasgow coma scale (gcs) \> 8 * german speaking * burn accident or road traffic accident exclusion criteria: * glasgow coma scale (gcs) \< 9 * more than 2 weeks in the pediatric intensive care unit * no command of german * previous mental retardation

Keywords: posttraumatic stress prevention children acute stress disorder due to burn injury or injuries associated with road traffic accidents
long-term outcomes of autologous transobturator rectus fascia sling for treatment of female stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases, so long-term outcomes needs to be verified.

stress urinary incontinence (sui) is defined as involuntary passage of urine with rising intra-abdominal pressure. sui is a common problem affecting 18-26.4% of women. over the last two decades, sui treatment has shifted to a mid-urethral sling (mus) or a mesh-based bladder neck procedure. although the surgery was believed to be relatively safe, there has been a steep rise in the number of reported cases of their erosion into the lower urinary tract. several options outside of synthetic mid-urethral sling placement exist, such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection. each has its limitations, whether related to morbidity or efficacy. the autologous slings most commonly used are the fascia lata and the rectus fascia, and they are placed at the urethra-vesical junction through the 'retropubic' approach. in an attempt to present the benefits of a "transobturator" surgical approach and avoiding risks associated with synthetic sling material, linder and elliott, 6performed a novel technique for autologous urethral sling placement via a" trans obturator" approach for managing female sui. autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases. notably, no patients had post-operative voiding dysfunction that necessitated sling release, and there were no major (clavien iii-v) complications.the aim of this study is to report long-term transobturator sling outcomes using autologous rectus fascia for sui in women.

Eligibility criteria:
inclusion criteria: * women with genuine stress urinary incontinence. * mixed urinary incontinence with predominant stress element. * refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment. exclusion criteria: * mild stress urinary incontinence with improvement on conservative therapy or patients refusing surgical treatment. * mixed incontinence with predominant urge urinary incontinence. * associated local abnormalities (e.g. cystocele). * recent or active urinary tract infection. * recent pelvic surgery. * neurogenic lower urinary tract dysfunction. * previous surgery for stress urinary incontinence. * pregnancy * less than 12 months post-partum. * other gynaecologic pathologies affecting bladder functions ( eg,large fibroids) * genito-urinary malignancy. * current chemo or radiation therapy.
analgesia evaluation of an ultrasound-guided technique for inguinal hernia surgery in children in children

Conditions: Inguinal Hernia; Surgery; Paediatric

Summary: the basis for the transversalis fascia plane (tfp) block involves infiltration of local anaesthetic blocking the ilioinguinal and iliohypogastric nerve which are located between the fascia of the transversus abdominis muscle and the transversalis fascia. the fascia of the transversus abdominis muscle, also called the thoracolumbar fascia, is formed when the transversus abdominis and internal oblique muscles taper off posteriorly into a common aponeurosis and abuts the lateral border of quadratus lumborum muscle. the transversalis fascia is a thin aponeurotic membrane which lies between the transversus abdominis muscle and the extraperitoneal fascia, and is part of the general layer of fascia lining the abdominal cavity. thus the tfp block is said to be suitable for lower abdominal surgery. this study was designed obtain the analgesic efficacy of ropivacaine 0.375% for ultrasound-guided (usg) tfp block for paediatric patients undergoing laparoscopic inguinal hernia.

methods: thirty-two asa 1 or 2 patients, aged 6 months to 12 years old undergoing laparoscopic inguinal hernia repair were recruited into this study. they were all given 0.4ml/kg of ropivacaine 0.375% after induction of anaesthesia. intra operative heart rate (hr), mean arterial pressure (map), cumulative fentanyl consumption as well as post operative flacc score, post operative nausea and vomiting incidence, time to first oral intake, parental satisfaction and complications were recorded.

Eligibility criteria:
inclusion criteria: all asa i or ii patients undergoing inguinal hernia repair exclusion criteria: parent's refusal, allergic to study drug

Keywords: ultrasound transversalis fascia ropivacaine inguinal hernia paediatric patients
phase iii ganciclovir +/- rgm-csf for aids-related cmv retinitis

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; gm-csf) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. to assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and gm-csf; to assess the changes in the expression of hiv p24 antigen in the serum and number of t4+ lymphocytes in the blood of patients receiving ganciclovir with or without gm-csf.


Eligibility criteria:
inclusion criteria patient must have the following: * aids as defined by cdc criteria. * retinitis as diagnosed by the study ophthalmologist. * performance status 0, 1, or 2. * ability to give informed consent and suitability of intravenous access for scheduled blood tests. * patient may have kaposi's sarcoma or basal skin cancer. exclusion criteria co-existing condition: patients with the following are excluded: * active acute infection requiring treatment. * corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy. * malignancy other than kaposi's sarcoma (ks) or basal skin cancer. patients with the following are excluded: * active acute infection requiring treatment. * corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy. * malignancy other than kaposi's sarcoma (ks) or basal skin cancer. prior medication: excluded: * granulocyte macrophage colony-stimulating factor (gm-csf). * colony stimulating factor. * interleukin 3. * excluded within 7 days of study entry: * zidovudine (azt). * trimethoprim / sulfamethoxazole (tmp / smx). * pyrimethamine. * excluded within 30 days of study entry: * biologic response modifiers. * cytotoxic agents. * investigational agents. prior treatment: excluded: * radiation therapy. required within 1 week of study entry: * one or more doses of ganciclovir.

Keywords: recombinant proteins retinitis aids-related opportunistic infections neutropenia ganciclovir drug therapy, combination granulocyte-macrophage colony-stimulating factor cytomegalovirus infections acquired immunodeficiency syndrome
debate on progesterone elevation on the day of triggering

Conditions: Progesterone; ART; Female Infertility; Embryo Transfer

Summary: the association between serum progesterone (p) levels, measured on the day of ovulation trigger, and the outcome of in vitro fertilization cycles, has been one of the major controversies in the field of ovarian stimulation endocrinology. this is a single-center retrospective cohort study. study duration period is from january 2012 to december 2016. all fresh embryo transfer (et) both at cleavage stage and blastocyst stage, performed in humanitas fertility center during the study period, were included.


Eligibility criteria:
inclusion criteria: * all fresh embryo transfers both at cleavage stage (day 2 and day3) and blastocyst stage (day 5) * thawed embryo transfer deriving from supernumerary embryos cycles, by p increase, by ohss, by other reasons (i.e inadequate endometrium, medical complications, etc) exclusion criteria: * thawed embryo transfers deriving from pgta.
csl312_3003 safety and pharmacokinetic study in subjects 2 to 11 years of age with hereditary angioedema

Conditions: Hereditary Angioedema (HAE)

Summary: the purpose of this study is to investigate the safety, pk / pd, and efficacy of sc csl312 for prophylactic treatment of pediatric subjects with hae.


Eligibility criteria:
inclusion criteria: 1. male or female 2. aged 2 to 11 years, inclusive, with body weight ≥ 10th percentile based on age 3. diagnosed with clinically confirmed c1-inh hae 4. experienced ≥ 2 hae attacks during the 6 months before screening exclusion criteria: 1. concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or hae type 3 2. use of c1-inh products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against hae attacks within a minimum of 2 weeks before the treatment period 3. participation in another interventional clinical study during the 30 days before the treatment period or within 5 half-lives of the final dose of the investigational product administered during the previous interventional study, whichever is longer 4. having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during screening 5. currently receiving a therapy not permitted during the study 6. being pregnant or breastfeeding.
study the knowledge and attitude towards epilepsy among relatives of people with epilepsy and their impact on the patient's quality of life

Conditions: Epilepsy

Summary: epilepsy is a common neurological condition that affects personal and familial behavior and social support . about 50 million people worldwide suffer from epilepsy and the prevalence of active epilepsy in developing countries is 5 to 10 per 100 persons . individuals with epilepsy may suffer from psychological issues such as depression, anxiety, and psychosis . accordingly, living with a person with epilepsy will provide some challenges, particularly at home. studies have reported that relatives of people with epilepsy have an increased risk of anxiety. epilepsy can inflict an enormous burden on both the people with epilepsy (pwe) and their family caregivers, decreasing their quality of life and daily efficiency.


Eligibility criteria:
inclusion criteria: * the participants will be the close relatives of people with epilepsy who had a close relationship with the patient and living in the same house. the respondents will include the mothers, fathers, brothers, sisters, or the husband/wife, sons of patients. the patients will be patients diagnosed of epilepsy for at least 6 months, who were using antiepileptic drugs. exclusion criteria: * the relatives not living in the same house or not in direct contact with the patients or younger than 16 years old will be excluded from the study. the persons who had major medical or mental health problems other than epilepsy that would affect qol will be excluded.

Keywords: epilepsy knowledge and attitude quality of life
lung ultrasound for the detection of pulmonary atelectasis in the perioperative period

Conditions: Postoperative Pulmonary Atelectases

Summary: atelectases (collapsed lung areas) of 15-20% of total lung occur in up to 90% of patients who are anaesthetized and intubated. the goal of the present prospective study is to detect atelectatic areas in the perioperative period in the lungs of patients undergoing elective laparoscopic surgery non-invasively and without x-ray exposure. results of lung ultrasound (lus) as the experimental method will be compared to the results of electrical impedance tomography (eit) as the reference technique for the detection of atelectasis. a device for peripheral oxygen saturation measurement (masimo radical-8) will detect changes in ventilation. the investigators want to confirm or disprove former findings of the appearance of intraoperative atelectases and to prove that ultrasound is a valid tool for detection of atelectases.


Eligibility criteria:
inclusion criteria: * male or female, * age 18 - 75 * bmi \< 30 * laparoscopic operation exclusion criteria: * pregnancy * pulmonary infection * chronic pulmonary diseases * morbid obesity
novel digital patient-reported outcomes tool for diabetes management

Conditions: Type 2 Diabetes

Summary: investigators will conduct a hybrid type 1 effectiveness-implementation randomized controlled trial (rct) to evaluate the effectiveness of imatter2 versus usual care on reduction in hba1c at 12-months (primary outcome) among patients with type 2 diabetes (t2d).


Eligibility criteria:
inclusion criteria: pcp group: * fulltime primary care provider (md/do, np) practicing at the participating family health centers or faculty group practices and * provide care to at least five patients with a diagnosis of t2d patient group: * have a diagnosis of t2d for ≥6 months; * have uncontrolled t2d defined as hba1c \>7% documented in the ehr on at least two visits in the past year; * fluency in english or spanish; * be willing to send/receive text messages; and * be \> 18 years of age. exclusion criteria: patient group: * refuse or are unable to provide informed consent; * have acute renal failure, end stage renal disease (esrd) or evidence of dialysis, renal transplantation, or other esrd-related services documented in the ehr; * have significant psychiatric comorbidity or reports of substance abuse (as documented in the ehr); * are pregnant or planning to become pregnant within 12 months; * currently participate in another t2d study; or * plan to discontinue care at the clinic within the next 12 months.